Read the Conversation
Conversation highlights:
- Argentina has established a unique collaborative relationship with its Ministry of Health, featuring frequent meetings and open communication that sets it apart from other Latin American countries.
- The country has transformed its clinical trial landscape since 2017 through regulatory reforms that reduced approval timelines and increased study volume.
- More than 90% of clinical trial investment in Argentina comes from foreign sources, representing over $700 million in economic impact for 2023.
- Argentina now has 11 sites approved for Phase I first-in-human studies, marking a significant expansion beyond its traditional Phase III focus.
- The industry faces growing complexity with rare disease studies and personalized medicine, requiring continuous adaptation and training.
- CAOIC is working with provincial governments to expand clinical trial access beyond Buenos Aires, ensuring patients across Argentina can participate in research.
EF: Tell us about your mission at CAOIC and your current priorities for Argentina.
MP: I’ve been working in clinical trials for more than 25 years, including my time at IQVIA, and this is my fourth year as president of CAOIC. This year also marks CAOIC’s 20th anniversary. We represent the leading CROs in the country and operate within CAEME with a clear focus on clinical research.
What makes Argentina stand out is the level of collaboration with the Ministry of Health. The interaction is frequent and open, which is not something we typically see across the region. From my experience working across Latin America, this is a clear differentiator.
The regulatory environment has also evolved. New guidelines aligned with ICH came into effect in December, building on reforms introduced around 2017. Since then, approval timelines have shortened significantly. At the same time, the number of studies has increased.
Our focus is to continue bringing more studies to Argentina. The country already offers strong medical expertise, experienced investigators, and high-quality standards. The Ministry plays an active role during studies through audits and inspections. This ensures patient safety and compliance throughout the process. Our track record reflects this. Argentina is a strong and reliable location for clinical trials across multiple therapeutic areas.
EF: How does the competition for clinical trial locations work within pharmaceutical companies?
MP: There is strong internal competition. Within companies, we need to demonstrate why trials should be conducted in Argentina. These studies provide patients access to new therapies that can change their lives.
They also generate qualified jobs and contribute to medical development. Every country is competing to attract students, so we must show that we are the best option. This comes down to enrollment, quality, and timelines. We are well-positioned. In my regional role, I see this across companies. All countries are competing to bring studies to their regions, especially when companies tend to focus mainly on the US or Europe.
EF: How has public perception of clinical trials changed, particularly regarding trust and safety?
MP: This used to be a challenge, but after COVID, public awareness increased significantly. People now better understand what clinical trials are and why they matter.
We always emphasize that a clinical trial conducted in Argentina follows the same protocol as in the US, Switzerland, or the UK. Patients receive the same treatment. There is a strong commitment from professionals to maintain high-quality standards, always with patient safety and rights at the center.
This is a highly regulated activity. We are testing whether drugs are safe and effective, so they are naturally sensitive. Our track record in quality is very solid.
EF: What’s the economic impact of clinical trials in Argentina?
MP: The latest report confirms sustained growth. In 2024, investment reached around $700 million, with more than 90% coming from foreign sources. This represents a significant economic contribution and a strong opportunity to position Argentina globally.
EF: Why should a dollar be invested in Argentina’s clinical trial sector?
MP: Argentina offers well-qualified medical doctors, strong institutions, and a solid Ministry of Health. The Ministry’s inspection programs ensure trials are conducted properly, which is essential for patient safety.
We also have more than 20 years of experience and well-trained staff. All CAOIC companies follow a strict ethics code. This is critical, as patients expect the highest standards.
In terms of performance, we have strong enrollment rates and access to relevant patient populations. We also benefit from key opinion leaders and internationally trained investigators. Overall, we have the capabilities required to conduct high-quality clinical trials.
EF: How is Argentina adopting digitalization and AI in clinical trials?
MP: We need to remain aligned with more developed markets, and this is not a major issue. There are differences between institutions, particularly in digitalization. Not all have electronic clinical records yet, but many are moving in that direction.
We are in a transition phase, similar to what we see globally. Sites are at different stages, but there is clear progress. Those involved in clinical trials are making serious investments. They understand that technology is essential, and we see ongoing efforts to adopt new solutions.
EF: What therapeutic areas are most important in Argentina’s clinical trial pipeline?
MP: Most trials originate from global pharmaceutical companies, so therapeutic areas reflect global trends. Oncology is the leading area. We are also seeing strong activity in obesity and autoimmune diseases, and maintain strong performance in areas such as cardiovascular disease.
One important shift is in the trial phases. Historically, Argentina focused on Phase III studies. We are now seeing growth in Phase I, supported by new regulations.
We currently have 11 sites approved for Phase I first-in-human studies. These are more complex and require highly trained teams, elevating the country´s research capabilities to the next level.
EF: How is CAOIC working to expand clinical trial access beyond Buenos Aires?
MP: Argentina is a federal country, so trials require approval at both national and provincial levels. Today, more than 50% of studies are conducted in Buenos Aires City, although patients often travel from other regions.
We are seeing progress in provinces such as Córdoba and Santa Fe. CAOIC, together with CAEME, is working with provincial authorities to improve frameworks and attract more studies.
It is important that patients across the country can access clinical trials without needing to travel. There is strong medical talent in provinces like Tucumán and Mendoza, and clear potential for expansion.
EF: How do you see clinical trials evolving based on your experience?
MP: The changes have been remarkable. When I started, everything was paper-based. Today, data is electronic and available instantly.
The field evolves quickly, so professionals must continuously adapt. During COVID, we had to enroll large numbers of patients under new constraints. This required rapid adjustment.
We are also seeing increasing complexity. Many studies now focus on rare diseases, where recruitment is more challenging. This is essential to improve outcomes for patients who currently lack treatment options. I remain optimistic. The goal is not only to live longer, but to live better. New therapies will improve the quality of life across all age groups, with a meaningful impact on patients and their families.
EF: What initiatives does CAOIC have for training and attracting new talent?
MP: This is our main challenge for future growth. Clinical research is highly regulated, and companies require trained professionals with experience. This is not easy to scale quickly.
We work with FEFIM on training programs and collaborate with universities to raise awareness, since this career path is not widely covered. Interest is growing, but training takes time. Practical experience remains essential. Companies are investing in training, and CAOIC plays an important role in supporting talent development.
EF: What’s your final message to healthcare leaders?
MP: Argentina is a strong destination for clinical trials. We offer solid regulatory timelines, high-quality standards, experienced investigators, and a strong Ministry of Health. We are ready to receive more studies and deliver the level of quality that patients expect.
